BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACHOICE

    MDR report key: 1964755 · Received December 23, 2010

    Report

    Report Number
    2210968-2010-01720
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    MKN
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT AN ENDOMETRIAL THERMAL ABLATION PROCEDURE ON AN UNK DATE. DURING THE PROCEDURE, THE BALLOON BROKE INSIDE OF THE PT. IT WAS DURING ABLATION THERAPY. THERE WERE NO ADVERSE PT CONSEQUENCES REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACHOICE CATHETER, BALLOON, TRANSCERVICAL MKN ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK